Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation
Authors: Nassir F. Marrouche, Oussama Wazni, Christopher McGann, Tom Greene, J. Michael Dean, Lilas Dagher, Eugene Kholmovski, Moussa Mansour, Francis Marchlinski, David Wilber, Gerhard Hindricks, Christian Mahnkopf, Darryl Wells, Pierre Jais, Prashanthan Sanders, Johannes Brachmann, Jeroen J. Bax, Leonie Morrison-de Boer, Thomas Deneke, Hugh Calkins, Christian Sohns, Nazem Akoum, Ahmad Abdul Karim, Alexander Costea, Alexander Leber, Andrzej Lubinski, Arif Elvan, Bengt Herweg, Bruce Koplan, Chris Jones, Christian Mahnkopf, Christian Sohns, Darryl Wells, David Wilber, Doug Packer, Emile Daoud, Felipe Atienza, Felipe Bisbal, Francis Marchlinski, Gerhard Hindricks, Gianluca Pontone, Heidi Estner, Helmut Puererfellner, Hemanth Ramanna, Hugh Calkins, Johannes Brachmann, Jon Kalman, Juergen Siebels, Lucas Boersma, Marco Gotte, Margot Vloka, Mattias Duytschaever, Mont Lluís, Moussa Mansour, Nassir Marrouche, Nazem Akoum, Oussama Wazni, Peter Kistler, Pierre Jais, Prashantan Sanders, Reza Wakili, Rukshen Weerasooriya, Saman Nazarian, Sandep Gautam, Suneet Mittal, Thomas Deneke, Thomas Maurer, Thomas Neumann, Vivek Reddy, William Spear
Journal: JAMA (2022)

Ablation of persistent atrial fibrillation (AF) remains a challenge. Left atrial fibrosis plays an important role in the pathophysiology of AF and has been associated with poor procedural outcomes.To investigate the efficacy and adverse events of targeting atrial fibrosis detected on magnetic resonance imaging (MRI) in reducing atrial arrhythmia recurrence in persistent AF.The Efficacy of Delayed Enhancement-MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation of Atrial Fibrillation trial was an investigator-initiated, multicenter, randomized clinical trial involving 44 academic and nonacademic centers in 10 countries. A total of 843 patients with symptomatic or asymptomatic persistent AF and undergoing AF ablation were enrolled from July 2016 to January 2020, with follow-up through February 19, 2021.Patients with persistent AF were randomly assigned to pulmonary vein isolation (PVI) plus MRI-guided atrial fibrosis ablation (421 patients) or PVI alone (422 patients). Delayed-enhancement MRI was performed in both groups before the ablation procedure to assess baseline atrial fibrosis and at 3 months postablation to assess for ablation scar.The primary end point was time to first atrial arrhythmia recurrence after a 90-day blanking period postablation. The primary safety composite outcome was defined by the occurrence of 1 or more of the following events within 30 days postablation: stroke, PV stenosis, bleeding, heart failure, or death.Among 843 patients who were randomized (mean age 62.7 years; 178 [21.1%] women), 815 (96.9%) completed the 90-day blanking period and contributed to the efficacy analyses. There was no significant difference in atrial arrhythmia recurrence between groups (fibrosis-guided ablation plus PVI patients, 175 [43.0%] vs PVI-only patients, 188 [46.1%]; hazard ratio [HR], 0.95 [95% CI, 0.77-1.17]; P = .63). Patients in the fibrosis-guided ablation plus PVI group experienced a higher rate of safety outcomes (9 [2.2%] vs 0 in PVI group; P = .001). Six patients (1.5%) in the fibrosis-guided ablation plus PVI group had an ischemic stroke compared with none in PVI-only group. Two deaths occurred in the fibrosis-guided ablation plus PVI group, and the first one was possibly related to the procedure.Among patients with persistent AF, MRI-guided fibrosis ablation plus PVI, compared with PVI catheter ablation only, resulted in no significant difference in atrial arrhythmia recurrence. Findings do not support the use of MRI-guided fibrosis ablation for the treatment of persistent AF.ClinicalTrials.gov Identifier: NCT02529319.